The Early Intervention and Prevention of Diabetes Foot
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 主要终点
- Peripheral arterial occlusive disease
研究概览
简要总结
Peripheral neuropathy is just assessed by determination of Vibration sensation, pressure sensation, superficial pain or temperature. The most commonly used technique for diagnosis of peripheral neuropathy is nervous conduction (NC) and electromyography (EMG). But EMG/NC is bothersome and techniques using electric currents to measure NC and needles to study muscle innervations are uncomfortable.
Quantitative NeuroSensory Testing (QST) is essential in the evaluation of small-caliber A-delta and C-fibers, the primary transmitters of thermal and pain sensation. QST can demonstrate neurosensory abnormalities when it is non-invasive test, selective to small fibers despite negative EMG/NCV finding.
The investigators predict QST can be used for the early diagnosis and follow-up of small-fiber neuropathy in diabetes patients. The investigators also predict the early evaluation of diabetes neuropathy with QST can reduce the diabetes patient progress to advance stage of DM foot or limb amputation.
详细描述
Patients will be divide into 4 groups (groups 1 to 4 will be divided by Q-Sense QST (TSA II) . The patient groups will be defined as the followings:
- Group 1: 100 diabetes patients without neuropathy, Q-Sense normal.
- Group 2: 100 diabetes patients with neuropathy, Q-Sense abnormal but no evidence of PAOD.
- Group 3: 100 diabetes patients with neuropathy, Q-Sense abnormal , PAOD (＋), but no foot ulceration
- Group 4: 100 diabetes patients with neuropathy, PAOD(＋) , and foot ulceration QST will perform using the Medoc device (TSA2001/VSA3001) following previous published procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Group 1: 100 diabetes patients without neuropathy, Q-Sense normal.
- •Group 2: 100 diabetes patients with neuropathy, Q-Sense abnormal but no evidence of PAOD.
- •Group 3: 100 diabetes patients with neuropathy, Q-Sense abnormal , PAOD (＋), without foot ulceration.
- •Group 4: 100 diabetes patients with neuropathy, PAOD (＋), and foot ulceration.
排除标准
- •Poorly controlled hypertension (SBP≥150 under regular medical treatment)
- •Thyroid disease
- •Pregnancy
- •Have been diagnosed malignancy
- •Liver cirrhosis
结局指标
主要结局
Peripheral arterial occlusive disease
时间窗: month 0,6,12
To see the correlation between diabetes neuropathy (by Q sense measurement) and severity of peripheral arterial occlusive disease ( at baseline, 6 months and 12 months).
Lipid profile
时间窗: month 0,6,12
To see the correlation between diabetes neuropathy (by Q sense measurement) and lipid profile ( at baseline, 6 months and 12 months).
Glycohemoglobin (HbA1c)
时间窗: month 0, 6, 12
To see the correlation between diabetes neuropathy (by Q sense measurement) and glycemic control status ( at baseline, 6 months and 12 months).
Diabetes nephropathy ( macro-albuminuria (UACR ≧300 mg/g) ，micro-albuminuria (UACR: 30 - 300 mg/g))
时间窗: month 0,6,12
To see the correlation between diabetes neuropathy (by Q sense measurement) and albuminuria status ( at baseline, 6 months and 12 months). Check the albuminuria status by the criteria (macro-albuminuria (UACR ≧300 mg/g) ，micro-albuminuria (UACR: 30 - 300 mg/g))
次要结局
- Diabetes foot(month 0, 6, 12)
- major lower leg events ( lower leg amputation or revascularization)(month 0,6,12)
- Major cardiac events ( myocardial infarction, strokes and cardiac related death)(month 0,6,12)